Pediatric CancerPhase 1ERIBULINNCT02082626
Study of Eribulin in Children With Cancer to Determine Safety
A Phase 1 study testing Eribulin mesylate in people with Pediatric Cancer and Solid Tumors, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a study for children with cancer with no curative treatment options. The investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. This study is designed to determine a safe dose the investigators can give to children in larger studies. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Pediatric Cancer, Solid Tumors, Lymphoma
- What is being tested?
- Eribulin mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2014to Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: ≤ 21 years of age at the time of study enrollment
- Diagnosis: refractory or recurrent solid tumors, including lymphomas, except those with CNS tumors or known CNS metastases
- Disease Status: measurable or evaluable disease
- Adequate organ function as defined in protocol
Who cannot join
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
This is a study for children with cancer with no curative treatment options. The investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. This study is designed to determine a safe dose the investigators can give to children in larger studies. The investigators will be monitoring the children on this study for the safety of the treatment and levels of eribulin in the blood after treatment. The investigators will also study the effect of the agent on the cancer.
Read the detailed description
This is a phase I study of eribulin, a novel tubulin inhibitor in children with relapsed and refractory solid tumors including lymphoma. Dose escalation will be performed in a classic 3+3 design starting with 75% of the adult maximum tolerated dose (MTD). Pharmacokinetics will be done on each patient. Primary endpoint will be the pediatric MTD.
- Conditions
- Pediatric Cancer, Solid Tumors, Lymphoma
- Being tested
- Eribulin mesylate
- Keywords
- Phase I, Pediatric, Cancer, Lymphoma, Eribulin
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin mesylateDrug
Also called Halaven
| Study group | Role | What they receive |
|---|---|---|
| Eribulin | Experimental | All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients. Receives: Drug: Eribulin mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
Measured: 1 year
Secondary outcomes (3)
Pharmacokinetics of eribulin in children with cancer
13 blood samples will be drawn from each subject over first 8 days of protocol to measure serum levels of the agent eribulin.
Measured: 8 days after first dose
Tumor expression of BRCP and ABCB1
Archival tumor samples from each subject will be stained for expression of BRCP and ABCB1, transporter proteins responsible for some resistance to chemotherapy. Will compare expression and response data
Measured: 1 year
Tumor response
Subjects receiving eribulin will have scans approximately every 6 weeks to assess whether the tumors are growing, shrinking, or remaining stable.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study start1 Feb 2014
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Competing study opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene Y McNall-Knapp, MD, Principal investigator, University of OklahomaAmanda Linz, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082626
- Sponsor's protocol ID
- 3812
- Acronym
- ERIBULIN
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2014
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT02082626
- Acronym / sponsor ID
- ERIBULIN / 3812
- Conditions
- Pediatric Cancer, Solid Tumors, Lymphoma
- Keywords
- Phase I, Pediatric, Cancer, Lymphoma, Eribulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Competing study opened
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study for children with cancer with no curative treatment options. The investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. This study is designed to determine a safe dose the investigators can give to children in larger studies. The investigators will be monitoring the children on this study for the safety of the treatment and levels of eribulin in the blood after treatment. The investigators will also study the effect of the agent on the cancer.
Detailed description
This is a phase I study of eribulin, a novel tubulin inhibitor in children with relapsed and refractory solid tumors including lymphoma. Dose escalation will be performed in a classic 3+3 design starting with 75% of the adult maximum tolerated dose (MTD). Pharmacokinetics will be done on each patient. Primary endpoint will be the pediatric MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin | Experimental | Drug: Eribulin mesylateAll patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: ≤ 21 years of age at the time of study enrollment
- Diagnosis: refractory or recurrent solid tumors, including lymphomas, except those with CNS tumors or known CNS metastases
- Disease Status: measurable or evaluable disease
- Adequate organ function as defined in protocol
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eribulin mesylateAlso: Halaven | Drug | Eribulin |
Primary outcome
Maximum tolerated dose
Time frame: 1 year
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
3 secondary outcomes
Pharmacokinetics of eribulin in children with cancer
Time frame: 8 days after first dose
Tumor expression of BRCP and ABCB1
Time frame: 1 year
Tumor response
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Competing study opened). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Y McNall-Knapp, MD principal investigator
University of Oklahoma
Amanda Linz, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eribulin mesylate in people with Pediatric Cancer and Solid Tumors, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Competing study opened). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.